Good morning, ladies and gentlemen. My name is Taryn, and I will be your operator today. Welcome to Knight Therapeutics fourth quarter and year-end 2022 results conference call. Before turning the call over to Samira Sakhia, President and CEO of Knight, listeners are reminded that portions of today's discussion may, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. The company considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions that these assumptions regarding future events, many of which are beyond the control of the company and its subsidiaries, may ultimately prove to be incorrect. The company disclaims any intention or obligation to update or revise any forward-looking statements, whether a result of new information, future events, except as required by law.
We would also like to remind you, questions during today's call will be taken from analysts only. Should there be any further questions, please contact Knight's Investor Relations Department via email to info@knighttx.com or via phone at 514-484-4483. I would like to remind everyone that this call is being recorded today, March 23, 2023, and would now like to turn the meeting over to your host for today's call, Samira Sakhia. Please go ahead, Ms. Sakhia.
Thank you, Taryn. Good morning, everyone, welcome to Knight Therapeutics fourth quarter and year-end 2022 conference call. I am joined on today's call with Amal Khouri, our Chief Business Officer, Arvind Utchanah, our Chief Financial Officer, Jeff Martens, our Global VP Commercial. I'm excited to announce that we delivered another great year in 2022 and reported record revenues of over $290 million, a growth of 21% over last year, as well as record adjusted EBITDA of over $54 million, an increase of 42% over last year. This growth was generated by the full year effect of Exelon, the impact of our recent launches in Colombia, as well as continued growth from our key promoted products. We have also executed on all aspects of our portfolio strategy.
We in-licensed AKYNZEO, a product with existing sales in our key markets, further expanded our innovative pipeline with the in-licensing of fostamatinib from Rigel. We also added three products to our branded generic pipeline, which include the rights to the two largest markets in LATAM, Brazil and Mexico. On the regulatory front, we continue to advance the pipeline, submitted tafasitamab or Minjuvi in Brazil, Colombia, and Argentina, as well as two branded generic products in each of Chile and Colombia, obtained the regulatory approval of Palbociclib in Argentina. In addition to delivering record results and advancing our pipeline, 2022 was very productive as we completed the integration of GBT and fully onboarded Exelon and AKYNZEO. Turning now to the NCIB. During the year, we purchased approximately 5.6 million common shares for aggregate cash consideration of over CAD 30 million.
Subsequent to the quarter, Knight has purchased an additional 1.3 million common shares for aggregate cash consideration of CAD 6.5 million. The average purchase price of the shares purchased through the NCIB launched in July 2022 was CAD 5.31 per share. I'm now gonna turn the call over to Jeff to provide more details on our product results.
Thank you, Samira. In 2022, as Samira mentioned, we have delivered record revenues of over CAD 290 million, an increase of over CAD 48 million on a constant currency basis, or 20% over prior year. We grew across all of our therapeutic areas due to the increasing market penetration of our new launches, as well as the full year acquisition effect of Exelon. Moving to our oncology hematology portfolio. During the year, revenues, excluding hyperinflation, were CAD 105.5 million, a growth of CAD 16.4 million or 18% versus the same period last year. This includes a contribution from our key promoted brands, including new launches of Lenvima, Halaven, and Rembre in Colombia in the first quarter of 2022.
The growth of our promoted products in all territories and the addition of AKYNZEO in Brazil and Canada. This increase was partially offset by a decline in sales of certain branded generic products due to their life cycle and entrance of new generic competitors. We delivered revenues of CAD 116.5 million, excluding hyperinflation. Our portfolio grew by CAD 29 million due to an increase in patient treatments as our markets reduced COVID-19 restrictions, growth of our key promoted products and a one-time sales contract with the Ministry of Health in Brazil for AmBisome. We recorded CAD 7.5 million in the quarter, which represents 40% of the full value of the contract, and we expect to deliver the balance in the first half of 2023.
This growth is offset by an estimated CAD 14.2 million due to lower COVID-related demand for certain of our infectious disease products that were used to treat invasive fungal infections associated with COVID-19 and the planned transition and termination of the Gilead agreement effective July 1, 2022. Moving to our other specialty portfolio. During the year, revenues excluding hyperinflation were CAD 69.8 million, an increase of CAD 21.3 million compared to prior year. This increase is mainly due to the full year effect of Exelon and the change in accounting treatment from net profit transfer to recognition of net revenues and related cost of sales. I will now turn the call over to Arvind to provide an update on our financial results.
Thank you, Jeff. In the course of this conference call, I will refer to EBITDA and adjusted EBITDA, which are non-IFRS measures. Knight defines EBITDA as operating income or loss, excluding amortization and impairment of intangible assets, depreciation, purchase price, accounting adjustments, and the impact of accounting under hyperinflation, but to include costs related to leases. Adjusted EBITDA excludes acquisition costs and non-recurring expenses. I will go directly to gross margin since Jeff has already discussed our revenues. For the fourth quarter of 2022, excluding the impact of hyperinflation, we reported gross margin of $41.9 million, or 50% of revenue, compared to $28.6 million or 51% of revenue in the same period last year.
For the year ended December 31, 2022, gross margin, excluding hyperinflation, was CAD 150.3 million or 52% of revenue, compared to CAD 118.8 million or 50% of revenue in the same period last year. The increase in gross margin as a percentage of revenue is due to the change in product mix as well as the full year effect of the acquisition of Exelon. Moving on to our operating expenses, excluding hyperinflation, amortization and impairment of intangible assets. For fourth quarter, our operating expenses were CAD 29.2 million, an increase of CAD 4.6 million compared to the same prior year period. For the year ended December 31, 2022, our operating expenses were CAD 99.3 million, an increase of CAD 15.2 million versus last year.
As we return to normal commercial activities, we see an increase in our sales, marketing and medical costs for our key promoted brands, including promotion spend behind the relaunch of Exelon and AKYNZEO. In addition, we saw an increase in compensation expenses as we strengthen our structure, including the management team and certain variable costs such as logistic expenses, which rose as a function of higher sales. Moving on to adjusted EBITDA. For the fourth quarter of 2022, we reported CAD 13.8 million, an increase of CAD 8.1 million or 143% compared to the same prior period. For the year ended December thirty-first, 2022, our adjusted EBITDA was a record CAD 54 million, an increase of CAD 16 million or 42% over the same prior year period.
Moving on to impairment of non-current assets, which is not reflected in our adjusted EBITDA. For the year ended December 31, 2022, under IFRS, we recorded an impairment of CAD 24 million, of which CAD 21.6 million relate to PP&E and intangible assets in Argentina. The main reason for the write down in Argentina is the increase in the value of non-monetary assets due to the hyperinflation adjustment under IFRS. Under hyperinflation accounting, the net carrying value of non-monetary assets, including PPE and intangible assets, is adjusted by the inflation index and converted back to Canadian dollar at the closing rate of the reporting period. During a period where the inflation index is higher than the devaluation of the Argentine peso relative to the Canadian dollar, the net carrying value of the non-monetary assets will increase in Canadian dollar, which can lead to an impairment.
Now moving on to gains or losses on our financial assets, which are not reflected in our adjusted EBITDA. In 2022, we recorded CAD 20.7 million of net unrealized losses on financial assets measured at fair value to profit or loss. The loss is driven by the market-to-market adjustment of underlying assets as a result of a decrease in the share prices of the publicly traded equities held by our strategic funds. Moving on to our cash flows. In 2022, Knight generated cash inflows from operations of CAD 40.5 million, including a net working capital investment of just under CAD 10 million, mainly due to the onboarding of Exelon and AKYNZEO. Finally, in December, we closed a loan with the International Finance Corporation for CAD 52 million, denominated in Brazilian real, Colombian, Mexican, and Chilean pesos.
Five-year loan has customary financial and non-financial covenants and is secured against certain assets of Knight as well as a restricted cash collateral of 35% of the loan balance. Depending on the currency, the interest rates on the loan range between 7.9%- 15.8% annually.
Knight expects its interest expense to increase in 2023. The loan further strengthens our balance sheet while providing a natural hedge against future currency depreciation in the key markets in which we operate. I will now turn the call back to Samira for concluding remarks.
Thank you, Arvind. Now turning to our financial outlook for 2023. Excluding the impact of IAS 29 or hyperinflation, Knight expects to generate revenues of $280 million-$300 million and adjusted EBITDA between 13%-15% of revenues. I'd like to remind everyone that this guidance is provided on a non-GAAP basis due to the difficulty of predicting Argentinian inflation rates. The guidance is also based on a number of assumptions which are described in our press release. Should any of the assumptions differ, the financial outlook and the actual results may vary materially. Our team has been extremely successful executing on our Pan American ex-U.S. strategy and has built a profitable business with a unique platform and a strong foundation from where to continue growing over the long term.
We ended 2022 by delivering record revenues and record adjusted EBITDA as a result of growing our current portfolio as well as adding new products that leverage our existing platform. Looking ahead, while we face headwinds with the entrance of new competitors on certain of our branded generics products, as well as incur investments related to launch products, Knight is expected to continue to generate strong cash flows from operations. With over CAD 150 million of cash and CAD 175 million of financial assets, we remain well positioned to execute on our mission to acquire, in-license, develop, and commercialize pharmaceutical products in Latin America and Canada. Thank you for your support and confidence in the Knight team. This concludes our formal remarks. I'd like to now open up the call for questions. Back to you, Taryn.
Thank you. Before we begin, may I please remind you, questions during today's call will be taken from analysts only. Should there be any further questions, please contact Knight's Investor Relations Department via email to info@knighttx.com or via phone at 514-484-4483. If you would like to ask a question, please press star followed by one on your telephone keypad. If you are using a speakerphone, please lift your handset before pressing any key. If you would like to withdraw your question, please press star two. Again, that's star 1 if you'd like to ask a question. We'll take our first question from David Martin with Bloom Burton. Sir, your line is now open. Please go ahead.
Good morning. A few questions. Great quarter. You mentioned facing generics in the upcoming year. I'm wondering, is this year expected to be more heavily genericized than in the past, or is this pretty status quo as far as generic threats? Is Exelon one of the products where you anticipate generic threats?
Thank you, David. There's a couple of different dynamics, whether it's on our innovative or our branded generics portfolio. When I look at our branded generics portfolio, it's kind of a life cycle issue. Some of the generics that have been the large contributors are facing more competition, more new entrants in that same molecule in the next year. When it comes to our innovative portfolio, including Exelon, we've known about generics on Exelon. We face already some generics. We do expect, depending on the market, either a new entrant or a couple more new entrants. For the year, we're still expecting it to be generally flattish as a brand.
Okay. You mentioned the AmBisome one-time contract. I think you said seven and a half million received to date, which is 40% of it. Was that all in Q4? Then when do you expect to receive the remaining 60%?
It was all in Q4, the CAD 7.5 million related to AmBisome, and the second portion of that order is supposed to deliver in the first half.
First half. Okay. Lastly, can you give any commentary on your business development pipeline right now? Does it look as strong as ever? Have there been any changes that you've seen?
Good morning. This is Amal. Yes, the pipeline is very, the deal flow is very healthy. The team is very active. We continue to look at opportunities along all three work streams. Acquisitions of products and portfolios and licensing of innovative products, as well as growing our branded generics portfolio. Whether it's internal development or in licensing. The team remains quite active along all three.
Okay, thanks. That's it for me.
Thank you, David.
We'll take our next question from Endri Leno with National Bank. Please go ahead.
Good morning. Thanks for taking my question. The first one is a bit more related to guidance, what I wanted to ask is the products that are facing generics competition in 2023, is there any kind of new product that you can launch to counter some of that, be it branded generics or new ones, or do we expect that generics impacts to continue throughout the year and into 2024? Basically, can you offset that with any new things?
We are offsetting. When it comes to our branded generics portfolio, it's kind of as they mature, new entrants come in. You see more of a price erosion and a margin erosion. That's really what we're seeing going into 23. The way we're countering that is obviously through the promotional efforts on our innovative products that are growing. We're also launching some branded generic products ourselves, new products. You see that in the new launches in our press release. The issue that we have is kind of a timing of when is the new launches happening versus as the erosion. This is why our BD team has been extremely busy on all three fronts: acquisition, in-licensing, as well as the generics portfolio. We will continue to really strengthen the portfolio to be able to manage these waves that are normal.
Okay. No, great. Thank you. Thanks for the answer. In terms of the cost, I mean, do you expect any increases in the cost, for example, versus what you did in 2022, in 2023, or are they generally kind of more stable?
The when I look at kind of the dollars that we have in our OpEx this year, we expect 2023 to be flattish.
Great. Thank you. There was a mention, a comment on the press release about investing more in 2023, doing some investments. Can you specify what those investments could be? I mean, are they more in personnel, or are you adding any manufacturing capacity or any new launches or anything like that?
Well, as you know, a lot of our products, when I look at the innovative portfolio, there is a relaunch of Exelon, there is a relaunch of AKYNZEO. We are doing planning and prep for Minjuvi. We've Lenvima and Halaven in Colombia. Those are investments that are gonna continue to be ongoing. As I said before, the total value of those dollars is not gonna change between 2022 and 2023.
Okay, great. And one last one for me, I'll jump in the queue. The contract that you got from the Ministry of Health in Brazil, is there any reason... if you can characterize it and describe it a little bit, what is it for? Any reason why it could be only one time? Have they found another product, or is there a generic that's coming along or any kind of color there? What's the probability that Letate repeats again?
I think in this case, the government had some experience with AmBisome during the kind of the public side of the business, would have had some experience due to COVID. We suspect that they had shortages maybe on some of the competitor products that are cheaper, so we received this contract. We don't put a high likelihood of a renewal of this contract. We will ship the second half. We don't expect it again.
Yeah. Thanks. I'll jump in the queue. Thank you.
As a reminder, if you find that your question has been answered, you may remove yourself from the queue by pressing star two. If you'd like to join the queue, you may press star one at this time. We'll take our next question from Scott McAuley with Paradigm Capital. Please go ahead.
Morning, Samira. Yeah, congrats to you and the team on the strong quarter and finishing the year. Just one for me. The others, I think, have been answered. On the outlook for 2023, just looking at the adjusted EBITDA margins that you're expecting, you know, my back of the envelope shows that that would, you know, the number would come down year-over-year relative to 2022. Just, you know, despite the growth in the top line. Just wondering what you could share in terms of what's contributing to that kind of margin pressure on the bottom line despite the growth on the top line.
Sure. As, as we said, like where we're seeing the headwinds is really coming from our branded generics portfolio. As we manufacture those products for ourselves, those are high-margin products. When you see the impact of a decline in sales, it actually has a more, a heavier hit to the bottom line, and the loss of margin on that product drops straight to the bottom line.
Got it. I think you said you expect kind of costs and other things on personnel to be flattish. It's more on that gross margin impact from the branded generics.
Exactly.
Got it. That's great. Thank you very much. Again, congrats on the, on the great year.
Thank you.
We'll take our next question from Sahil Dhingra with RBC Capital Markets. Please go ahead.
Hi, good morning. Thanks. This is Sahil for Douglas Miehm. My first question is just wanted to confirm on Exelon. Is all the commercial rights being transferred to Knight? Is Q4 fully burdened with Exelon costs in terms of SG&A? That would be my first question, please.
Sure. In the case of Exelon, it has the, all of the MA transfers have been done. There is some smaller markets in Central America and Caribbean that remain, and won't really have a major impact on our numbers when they do switch over to us. When it comes to SG&A, we don't really do it by brand, but as I said earlier, when it comes to the total OpEx, we really don't expect that to change going into 2023.
Okay. The difference, my second question would be the difference between the delta for the guidance, it does imply on the lower end, you will be probably the revenue will decline, and that is mainly due to the branded generics, competition in the branded generics, or is there something else?
That's it. No, the real issue that we're dealing with is our, we face new entrants, the head-to-head competition from our branded generics portfolio. As that happens, what we see is that we have to lower our price. That's a straight margin hit that drops straight to the bottom line. It's really an issue of the portfolio. As we launch newer products, both on our innovative portfolio as well as on our GX portfolio, we'll ride this wave out going into the future.
My final question is, do you have certainty regarding the timing of these competitive products launching? Like, will there be an impact in particular quarter as you think about quarterly revenues or it is uncertain at the moment?
It'll really depend on the country and the product. It's kind of, yeah, hard to predict right now, but we do expect them coming in.
Okay, thank you. Those are all my questions.
Thank you.
Our next question will return to Endri Leno with National Bank. Please go ahead.
Thank you. Two more questions for me. The first one, it's more for the BG team, but when you're looking at new products, especially for 2023, are you looking at more at replacing some of the lost sales that you get from the branded generics? Or is the strategy still continuing to try and grow the footprint in Canada and in Mexico?
Hi, Endri, this is Amal. It's really all of the above, right? We look to bring in opportunities that would be immediately accretive. That would be products or portfolios or M&A with existing sales and existing profitability. We're also looking at the same time to bring in pipeline, and that's both innovative as well as branded generics. Really it's full steam ahead on all of the above.
That again, as Samira said earlier, the phasing issue that we're facing this year, you know, with our branded generics portfolio maturing and the pipeline not yet coming in already this year to compensate for that, the work that the team is doing is to make sure that going forward, we don't really have that temporary dip, but we're kind of, you know, building both with existing and pipeline.
I'm just gonna add, like if you look at kind of what we did. I'm just gonna add to her. If you look at what we did in 2021, we added Exelon, we added the Incyte products, as well as continued on the development side of our branded generics portfolio, and you see that with some of the submissions that we have and the approval that we have this year. When you look at 2022, you have kind of the similar idea in licensing of BG, in licensing of innovative with Rigel's product, as well as the addition of a product with existing sales with AKYNZEO. There's really nothing that's changed in our BD strategy. We're gonna continue to execute on the same strategy.
Okay. Great. As a follow-up , has have multiple changed at all, when you look at across your geographies, or have they remained as they were?
The deal landscape remains competitive. Of course, the level of competitiveness depends on the type of deal and type of product. We haven't seen anything kind of dramatically different in terms of valuations or multiple, but, you know, the landscape remains competitive.
Okay. A great thing to end it.
Go ahead.
Got it. Thank you. The last one for me is just more on the political side of things. Would you expect any impacts, especially when it comes to Brazil and Colombia? Have there been any regulatory or access changes in for 2023 that you anticipate?
That's a really great question. One of the things that we know similar to the rest of the market, and that's not really a political issue, it's more an economic issue, post-COVID, whether it's private payers or public payers or, generally even individuals on cash pay products, due to economic issues and inflation, everybody's trying to control budgets and spend. We do face that, and that's not just a Knight issue. I think it's a global pharma issue. When it comes to the political environment, there has been a lot of talk about pharma reform in each of Colombia and Brazil. Colombia, for example, has issued a reform package that they submitted. It is being highly debated, and may go into place, but probably not in the form that it's in today just because of the level of debate that we're seeing.
In the case of Brazil, they've talked about it, we really haven't seen anything. The one thing to remember is when it comes to the pharmaceutical industry, this is one where we know that our products are always gonna be necessary. It's really a question of the pricing, the reimbursement, one of the reasons why we want to maintain a diversified portfolio of innovative products as well as branded generics, this way we are able to adjust and bring value to those payers.
Okay, great. Thank you very much. That's it for me.
Once more, if you would like to ask a question, you may press star one on your telephone keypad now. That's star one if you'd like to ask a question. It appears there are no further questions at this time. Ms. Sakhia, I'd like to turn the conference back to you for any additional remarks.
Thank you, Taryn. Thank you for your confidence in the Knight team and for joining our Q4 2022 conference call. Have a great morning.
This concludes today's call. Thank you for your participation. You may now disconnect and have a great day.